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Name of Product: PROGUANIL HYDROCHLORIDE Chloroguanide Hydrochloride Proguanil Hydrochloride is 1-(4-chlorophenyl)-5- isopropylbiguanide hydrochloride. Formula: C11H16ClN5,HCl Category: Antimalarial. Mol. Wt.: 290.19 Dose: Suppressive, 100 to 300 mg daily.
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Sr. No.
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Analysis
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Specification
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1
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Description
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White, crystalline powder; odourless.
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2
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Solubility
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Soluble in ethanol (95%); slightly soluble in water; practically insoluble in chloroform and in ether.
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3
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Identification:
A:
D:
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By infra-red absorption spectrum
Gives the reactions of chlorides,
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4
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Acidity or Alkalinity
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To 35 ml of water maintained at 60o to 65o add 0.2 ml of methyl red solution, neutralise with 0.01M sodium hydroxide or 0.01M hydrochloric acid, add 0.4 g of the substance being examined and stir until dissolved. The resulting solution is not acidic and requires for neutralisation not more than 0.2 ml of 0.01M hydrochloric acid.
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5
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4-Chloroanilin
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Dissolve 0.10 g in 1 ml of 2M hydrochloric acid, add sufficient water to produce 20 ml, cool to 5o, add 1 ml of 0.05M sodium nitrite, allow to stand at 5o for 5 minutes, add 2 ml of a 5% w/v solution of ammonium sulphamate and allow to stand for 10 minutes. Add 2 ml of a 0.1% w/v solution of N-(1-naphthyl)ethylenediamine dihydrochloride, dilute to 50 ml with water and allow to stand for 30 minutes. Any magenta colour produced is not more intense than that obtained by treating in the same manner and at the same time 20 ml of a solution containing 1.25 m g of 4-chloroaniline.
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5
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Sulphated Ash
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Not more than 0.1%
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6
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Loss on Drying
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Not more than 0.5%, determined on 1 g by drying in an oven at 105o
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7
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Assay
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Proguanil Hydrochloride contains not less than 99.0 per cent and not more than 101.0 per cent of C11H16ClN5,HCl, calculated with reference to the dried substance.
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